Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1232 for:    cystic fibrosis
Previous Study | Return to List | Next Study

Assessment of Cystic Fibrosis Lung Involvement With UTE Pulse Sequences (MucoIRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02449785
Recruitment Status : Completed
First Posted : May 20, 2015
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
Non-invasive assessment of lung involvement is a crucial issue for the follow-up of cystic fibrosis patients. Currently, CT is the method of reference to evaluate and quantify the lung morphological changes in cystic fibrosis adults but it remains a radiation-based technique. MRI with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. The investigators' objective is to evaluate cystic fibrosis lung involvement using CT and MRI-UTE, and to test the agreement between both techniques.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: MR measurements of lung morphological changes in cystic fibrosis (Avanto dot, Siemens) Device: CT measurements of lung morphological changes in cystic fibrosis Not Applicable

Detailed Description:
Cystic fibrosis is a recessive autosomic fatal disease, affecting about 6000 people in France. Thanks to progress in symptomatic care, median survival is increasing. The lung involvement is the most common and responsible for most deaths. The evaluation of respiratory disease severity is based on pulmonary functional tests (PFT) and imaging. Multi-slice computed tomography (CT) is the method of reference to quantify lung involvement in cystic fibrosis. It detects respiratory lung involvement earlier than PFT, and it reveals lesions associated with the onset of respiratory exacerbations, the mortality increase and the reduction of quality of life. However CT provides ionizing radiation, thus limiting the possibility of long-term follow-up. MRI is a non-ionizing 3D imaging technique; nevertheless, lung MRI is technically challenging with the result that it is currently not used in routine practice. Indeed, both low proton density and susceptibility effects lead to very low signal intensity derived from lung parenchyma. Recently, pulse sequences with ultrashort echo time (UTE) have been implemented by the use of half radio-frequency excitations and radial projection reconstruction. These UTE sequences make it theoretically possible to retrieve more signal from the lung parenchyma. The investigators aim at using 3D T1-weighted UTE pulse sequences on a 1.5T magnet (Avanto dot, Siemens) in cystic fibrosis patients in order to assess lung involvement severity. Thirty three cystic fibrosis adults are expected to take part in the study. All will benefit from PFT, CT and MRI. The investigators' strategy is to establish a semi quantitative score of pulmonary severity (Helbich score) using MRI and CT in subjects, testing for correlations between MRI and CT measurements and assessing the reproducibility of lung lesions quantification using MRI. The investigators' objective is to demonstrate that MRI-UTE pulse sequence at 1.5T is accurate and reproducible in evaluating and quantifying pulmonary involvement in cystic fibrosis.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessment of Lung Involvement in Cystic Fibrosis Patients Using 1.5T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences
Actual Study Start Date : September 30, 2015
Actual Primary Completion Date : September 6, 2016
Actual Study Completion Date : September 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Cystic fibrosis adults Device: MR measurements of lung morphological changes in cystic fibrosis (Avanto dot, Siemens)
Device: CT measurements of lung morphological changes in cystic fibrosis



Primary Outcome Measures :
  1. Agreement between MRI and CT for scoring lung involvement in cystic fibrosis [ Time Frame: During MRI and CT, Day one ]

    MRI and CT evaluation of lung lesions quantification in cystic fibrosis will be assessed by 2 blind radiologists.

    Agreement between both evaluation will be assessed during statistical analyses after study completion.



Secondary Outcome Measures :
  1. Cystic fibrosis lesions scoring extracted from CT and MR images [ Time Frame: During MRI and CT, Day one ]

    MRI and CT evaluation of lung lesions quantification in cystic fibrosis will be assessed by 2 blind radiologists.

    Agreement between both evaluation will be assessed during statistical analyses after study completion.


  2. MRI cystic fibrosis reproductibility scoring over the time [ Time Frame: During MRI, Day one ]
    MRI cystic fibrosis scoring will be assessed a second time the same blind radiologist

  3. Correlation between MRI cystic fibrosis scoring and PFT indexes [ Time Frame: Day one ]
  4. Correlation between MRI cystic fibrosis scoring and exacerbation number [ Time Frame: 12 month after Day one ]
  5. Correlation between MRI cystic fibrosis scoring and quality of life [ Time Frame: Day one and 12 month after Day one ]
  6. Evolution of MRI cystic fibrosis scoring after one year [ Time Frame: 12 month after Day one ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cystic fibrosis adults
  • written informed consent

Exclusion Criteria:

  • Subjects without any social security or health insurance
  • Pregnancy
  • MRI contraindications: Magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants), metal inside the eye or the brain (aneurysm clip, ocular foreign body), cardiac valvular prosthesis (Starr-Edwards pre-6000), subject with claustrophobia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449785


Locations
Layout table for location information
France
University Hospital Bordeaux
Pessac, France
Sponsors and Collaborators
University Hospital, Bordeaux

Layout table for additonal information
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02449785     History of Changes
Other Study ID Numbers: CHUBX2014/11
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Keywords provided by University Hospital, Bordeaux:
Cystic fibrosis
MRI
UTE
CT
Exacerbation
Quality of life
Pulmonary function
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases